Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours after vaginal birth or cesarean section. In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth. The purpose of this prospective, non-randomized, feasibility pilot study is to obtain information on the safety and effectiveness of an investigational new medical device - Alma System, that is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
A prospective, non-randomized, feasibility pilot study that is intended to obtain information on the safety and effectiveness of the Alma System. Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage. The main questions are: 1. Rate of device related SAEs up to six weeks following device treatment. 2. Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure. 3. Rate of occurrence of uterine inversion of folding during or immediately after device procedure. Main tasks for participants: * sign the informed Consent form and enrolment * In case of PPH, treatment with Alma * Participate in 2 follow-up visits After the treatment- 1st upon discharge and 2nd after 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Subjects diagnosed with postpartum hemorrhage will receive the Alma System. This system comprises a soft silicone cylindrical device placed within the uterus. Gentle suction is applied, prompting the uterus to contract and reduce in size. This contraction compresses the blood vessels, halting the bleeding.
UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES
Nairobi, Kenya
RECRUITINGRate of Related SAEs
Rate of device related SAEs up to six weeks following device treatment.
Time frame: 6 weeks
Rate of Damage to Cervix, Uterus or Vagina
Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure
Time frame: When removing the Alma System at the end of the procedure
Rate of Occurrence of Uterine Inversion or Folding
Rate of occurrence of uterine inversion or folding during or immediately after device procedure
Time frame: When removing the Alma System at the end of the procedure
User Feedback on Placement of Alma
Rate of positive user feedback on device placement trans-vaginally
Time frame: When removing the Alma System at the end of the procedure
User Feedback on Connection to Vacuum
Rate of positive user feedback on connection to vacuum and maintenance of desired negative pressure
Time frame: When removing the Alma System at the end of the procedure
Rate of Uterine Contraction
Rate of uterine contraction to a level that reduces or stops blood flow
Time frame: When removing the Alma System at the end of the procedure
Time to Visible Reduction in Blood Flow
Time from insertion and start of negative pressure to visible reduction in blood flow
Time frame: When removing the Alma System at the end of the procedure
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